Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease: protocol of the PERION multicenter, two-arm, open-label, randomized trial

Table 1 Efficacy and safety of PERIOdontal treatment versus usual care for Nonalcoholic liver disease (PERION) inclusion criteria

Criteria type	Description of inclusion criteria
Sex and age	Men and women: 20–85 years of age
Diet and exercise therapy	Patients with NAFLD who did not respond to 3-month diet and exercise therapy
ALT levels	Patients with an ALT level of > 40 IU/L at the start of this study
Fatty liver	Patients with a diagnosis of fatty liver based on abdominal ultrasonography^a
Steatosis grade	Patients with the equivalent of steatosis grade ≥ 1 on CAP (using FibroScan) and/or PDFF (using MRI)^b
Fibrosis stage	Patients with the equivalent of fibrosis stage < 4 on TE (FibroScan) and/or MRE^c
Alcohol consumption	Patients with no habitual alcohol consumption (i.e., consumption of ethanol > 30 g/day in men and > 20 g/day in women)
Periodontitis	Patients with chronic moderate periodontitis (holding rate of periodontal pocket depth of > 4 mm is > 10 sites)
Other	Patients who can provide written consent to participate in this research in person, follow instructions during participation in this research, undergo protocol-specified physical examination and other examinations, and report symptoms or events

ALT alanine aminotransferase, CAP controlled attenuation parameter, MRE magnetic resonance elastography, MRI magnetic resonance imaging, NAFLD nonalcoholic fatty liver disease, PERION PERIOdontal treatment for NAFLD, PDFF proton density fat fraction, VCTE vibration-controlled transient elastography. ^aCriteria of fatty liver, as defined by the existence of hepatorenal echo contrast. ^bDefined by CAP ≥ 236 dB/m and/or PDFF ≥ 5.2%. ^cDefined by VCTE < 14 kPa and/or MRE < 6.7 kPa

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